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A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control

13 oktober 2016 bijgewerkt door: Rimidi Diabetes, Inc.

A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control

The benefit of drug therapy to persons with diabetes has been well established in clinical trials in terms of reducing cardiovascular risk, microvascular complications and mortality. However, treatment adherence and treatment effectiveness continue to be challenges in diabetes management.

Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic medications on an individual's glucose profile, allowing the clinician and their patient to visualize the anticipated outcome of a medical intervention. Use of this technology should allow for more targeted decision-making by the clinician and should facilitate a shared decision-making process with the PwD who is now privy to the thought process behind their medical management.

The proposed study is designed to test whether adding a decision support capability (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • Recruitment

    • Recruitment of persons with diabetes through a community diabetes management center according to inclusion and exclusion criteria below.
    • This is a three-armed study. Enrollees will be randomized to continue diabetes care with standard diabetes management in the Medication Management Clinic or the Intervention Group and compared to a matched cohort managed through their primary care physician (PCP) and standard of care.
    • The Intervention Group will be standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me with a connected glucometer.
    • Upon recruitment, PwD will be oriented to the Diabetes+Me application and instructed on how to complete a glucose profile and how to enter data into the application. Baseline hemoglobin A1C will be measured.
    • Enrollees will complete a brief survey of satisfaction with their diabetes management.

  • Study visits

    • The first study visit will be 2 weeks following enrollment.
    • Weight, number of medications, number of medication titrations, the presence of insulin and blood pressure will be measured at each study visit. Frequency of hypoglycemia in the preceding week will be documented at each visit. Adherence to medical prescription to be documented at each visit.
    • If the PwD has not entered data into Diabetes+Me this will be done at the beginning of each study visit.
    • At the first study visit, the HCP will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the next visit.
    • The second study visit will occur 5 weeks following the initial visit. The HCP and PwD will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the final visit.

The third and final study visit will occur 5 weeks following the second visit. The HCP and PwD will review the glucose profile from the previous week and identify if the PwD is meeting targets.

Studietype

Ingrijpend

Inschrijving (Verwacht)

129

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Physician diagnosis of type 1 or type 2 diabetes
  • Glycated hemoglobin > 9% within 3 months
  • Age 18-80
  • Not currently managed by study clinicians

Exclusion Criteria:

  • Pregnant
  • Active substance abuse
  • Severe hearing or visual impairment
  • No internet or email access

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention Group
Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer
Ander: Medication Management Clinic
referral to medication management clinic from primary care
Ander: Diabetes+Me plus connected glucometer
Use of software and medication modeling tool as add on to medication management standard of care
Actieve vergelijker: Standard Diabetes Management
Patient in standard diabetes management in the Medication Management Clinic
Ander: Medication Management Clinic
referral to medication management clinic from primary care
Geen tussenkomst: Primary Care
Matched cohort managed through their primary care physician (PCP) and standard of care.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Hemoglobin A1C
Tijdsspanne: change from baseline to 12 weeks
change from baseline to 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of hypoglycemic events per week
Tijdsspanne: change from 1st week to twelfth week
Decrease in frequency of hypoglycemia (# events per week
change from 1st week to twelfth week
Blood pressure
Tijdsspanne: change from baseline to 12 weeks
increase in percentage of patients with blood pressure in normotensive range
change from baseline to 12 weeks
BMI
Tijdsspanne: change from baseline to 12 weeks
decrease in BMI
change from baseline to 12 weeks
Healthcare provider satisfaction
Tijdsspanne: through study completion, an average of 1 year
healthcare provider satisfaction based on scoring of questionnaire
through study completion, an average of 1 year
A1C target attainment
Tijdsspanne: at 12 weeks
time to A1c goal attainment
at 12 weeks
Medication titrations needed
Tijdsspanne: 12 weeks
number of medication titrations over 12 week period needed to reach A1c goal
12 weeks
Patient satisfaction questionnaire
Tijdsspanne: through patient study completion, an average of 12 weeks
questionnaire addresses satisfaction with care and knowledge of diabetes self-management
through patient study completion, an average of 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rimidi Diabetes, Inc.

Onderzoekers

  • Hoofdonderzoeker: Michael Jardula, MD, Desert Oasis Healthcare

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2015

Primaire voltooiing (Verwacht)

1 oktober 2016

Studie voltooiing (Verwacht)

1 november 2016

Studieregistratiedata

Eerst ingediend

17 augustus 2016

Eerst ingediend dat voldeed aan de QC-criteria

13 oktober 2016

Eerst geplaatst (Schatting)

17 oktober 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

17 oktober 2016

Laatste update ingediend die voldeed aan QC-criteria

13 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RD-DOHC

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Onbeslist

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